3
Indication details
- Combined Agent(s)
- Letrozole
- Control Arm
- Letrozole
- FDA Therapeutic Indication
- Treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- HR+ HER2-
- Trial Name
- PALOMA-1/TRIO-18
- NCT Number
- NCT00721409
- Trial Phase
- Phase II
Approval details
- EMA Approval
- EMA (CHMP) September 2016 EC decision November 2016
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 10.2 months
- PFS Gain
- 10 months
- PFS HR
- 0.49 (0.32-0.75)
- OS Control
- 33.3 months
- OS Gain
- 4.2 months
- OS HR
- Not significant
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 8
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 14.08.2023
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.